US2010063116A1PendingUtilityA1

Use of pramipexole or a salt thereof for the treatment of parkinson's disease

49
Assignee: BOEHRINGER INGELHEIM INTPriority: Oct 30, 2006Filed: Oct 29, 2007Published: Mar 11, 2010
Est. expiryOct 30, 2026(~0.3 yrs left)· nominal 20-yr term from priority
Inventors:Jeffrey G. HuthElizabeth Keating
A61P 25/16A61P 25/28A61K 31/428A61P 25/00
49
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Claims

Abstract

The present invention refers to the use of pramipexole, pramipexole hydrochloride, pramipexole dihydrochloride or pramipexole dihydrochloride monohydrate for the manufacture of a medicament for the treatment of early Parkinson's disease by a maintenance, twice daily application.

Claims

exact text as granted — not AI-modified
1 . A method for treating early Parkinson's disease in a patient, comprising administering to said patient an effective amount of an immediate release formulation containing an active ingredient selected from the group consisting of pramipexole, pramipexole hydrochloride, pramipexole dihydrochloride and pramipexole dihydrochloride monohydrate, or any other pharmaceutically acceptable salt form of pramipexole, wherein the formulation is administered to said patient twice daily as a maintenance treatment. 
   
   
       2 . The method according to  claim 1 , wherein the total every day dosage is between 0.2 to 5.0 mg. 
   
   
       3 . The method according to  claim 1 , wherein the total every day dosage is between 0.25 to 2.5 mg. 
   
   
       4 . The method according to  claim 1 , wherein the total every day dosage is between 0.5 to 1.5 mg. 
   
   
       5 . The method according to  claim 1 , wherein the total every day dosage is between 0.5 and 0.8 mg. 
   
   
       6 . The method according to  claim 1 , wherein the total every day dosage is applied in two equal amounts. 
   
   
       7 . The method according to  claim 1 , wherein the period in-between the two takings is between 7 to 17 hours. 
   
   
       8 . The method according to  claim 1 , wherein the period in-between the two takings is between 8 to 16 hours. 
   
   
       9 . The method according to  claim 1 , wherein the period in-between the two takings is between 9 to 15 hours. 
   
   
       10 . The method according to  claim 1 , wherein the period in-between the two takings is between 10 to 14 hours. 
   
   
       11 . The method according to  claim 1 , wherein the period in-between the two takings is between 11 to 13 hours. 
   
   
       12 . The method according to  claim 1 , wherein the period in-between the two takings is 12 hours. 
   
   
       13 - 18 . (canceled) 
   
   
       19 . The method according to  claim 1 , wherein the immediate release formulation is a tablet which comprises 0.125 mg, 0.25 mg, 0.5 mg, 1.0 mg, or 1.5 mg of pramipexole dihydrochloride monohydrate and the inactive ingredients mannitol, corn starch, colloidal silicon dioxide, povidone, and magnesium stearate. 
   
   
       20 . A kit comprising an immediate release formulation containing an active ingredient selected from the group consisting of pramipexole, pramipexole hydrochloride, pramipexole dihydrochloride and pramipexole dihydrochloride monohydrate, or any other pharmaceutically acceptable salt form of pramipexole, and an instruction to administer the immediate release formulation twice daily. 
   
   
       21 . The kit according to  claim 20 , wherein the instruction is such that the total every day dosage is between 0.2 to 5.0 mg. 
   
   
       22 . The kit according to  claim 20 , wherein the instruction is such that the total every day dosage is between 0.25 to 2.5 mg. 
   
   
       23 . The kit according to  claim 20 , wherein the instruction is such that the total every day dosage is between 0.5 to 1.5 mg. 
   
   
       24 . The kit according to  claim 20 , wherein the instruction is such that the total every day dosage is between 0.5 and 0.8 mg. 
   
   
       25 . The kit according to any of claim, wherein the instruction is such that the total every day dosage is applied in two equal amounts. 
   
   
       26 - 37 . (canceled) 
   
   
       38 . The kit according to  claim 20 , wherein the immediate release formulation is a tablet which comprises 0.125 mg, 0.25 mg, 0.5 mg, 1.0 mg, or 1.5 mg of pramipexole dihydrochloride monohydrate and the inactive ingredients mannitol, corn starch, colloidal silicon dioxide, povidone, and magnesium stearate. 
   
   
       39 - 40 . (canceled)

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